Adjuvant CCRT vs CT in Minimal N2 NSCLC

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Approximately 15% of patients with non-small cell lung cancer are diagnosed with stage IIIA-N2 disease. However, this subgroup is heterogeneous, with lymph nodes that are only microscopically invaded to those that are radiologically visible with bulky ipsilateral mediastinal lymph node involvement. Surgical resection in selected patients results in 5-year survival rates of 7-24%.

The standard treatment for locally advanced clinical N2 disease is definitive concurrent chemoradiotherapy or induction chemotherapy (± radiation) followed by operation. However, in some patients, N2 status could be confirmed only after curative operation without any evidence of N2 diseases through preoperative evaluation methods (CT, PET, mediastinoscopy). We usually define those N2 disease found only after curative operation as microscopic N2, and do adjuvant chemotherapy, radiotherapy or concurrent chemoradiotherapy. However, little data about the adjuvant therapy for completely resected N2 disease have been available, Hence, we propose a randomized phase II study of adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of stage IIIA(N2) NSCLC that was completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video-assisted thorascopic surgery approaches were acceptable)

"Pathologic N2" disease (involvement of N2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis)

Age ≥18years

No known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis)